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Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure
This study has been completed.
Study NCT00182169   Information provided by McMaster University
First Received: September 12, 2005   No Changes Posted

September 12, 2005
September 12, 2005
July 1997
 
6-minute walk test distance (functional capacity)measured at baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy
Same as current
No Changes Posted
  • Cardiac Function measured with radionuclide angiography and echocardiography
  • Exercise capacity measured during treadmill testing (duration of exercise)
  • Quality of life measured with Minnesota Living with Heart Failure
  • Neurohormones
  • baseline, 3 months, and 6 months from the start of the study. Also measured at 3 months following discontinuation of therapy
Same as current
 
Evaluation of the Effect of Human Recombinant Growth Hormone in Patients With Advanced Heart Failure
Randomized, Placebo Control, Clinical Trial Evaluating the Effect of Human Recombinant Growth Hormone in Patients With Severe Congestive Heart Failure. The Growth Hormone In Heart Failure Trial (GIFT)

Prospective randomized, placebo controlled, clinical trial to evaluate the effect of human growth hormone supplementation compared with placebo to patients with severe heart failure for a duration of 6 months on exercise capacity, heart function and quality of life

 
Phase II
Interventional
Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Heart Failure
Drug: Human recombinant growth hormone
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
80
June 2005
 

Inclusion Criteria:

Individuals with a diagnosis of CHF, NYHA functional class III or IV symptoms, an EF of < 35 % estimated on radionuclide angiography (RNA) or 2D echo within the last 6 months, and a 6 minute walk distance of less than 400 meters. Patients must be stabilized on “CHF” therapy at the time of randomization.

Exclusion Criteria:

  1. Exercise limited by claudication, angina, neurological, pulmonary (FEV1 < 50%; FVC < 50%), or musculoskeletal disease.
  2. Active known malignancy; remission of < 5 years from the diagnosis of malignancy; patients with recurrence of malignancy are to be withdrawn from the study.
  3. Current diabetes with known retinopathy or patients with poorly controlled diabetes (ie. fasting glucose more than 13 mmol/l) or Type I diabetes mellitus.
  4. Any other non-cardiac condition that substantially decreases survival.
  5. Significant valvular stenosis or hypertrophic cardiomyopathy.
  6. Unable to comply with GH injection.
  7. Pregnancy or women of child bearing age not using adequate contraceptive means.
  8. Unstable angina, acute myocardial infarct, cardiac surgery, or PTCA within 3 months.
  9. Cor pulmonale.
  10. Acute myocarditis.
  11. Known need for cardiac surgery (e.g., valvular intervention, or CABG, or PTCA) within the next 6 months.
  12. Clinical hypothyroidism or hyperthyroidism with biochemical corroboration (TSH > 7 or < 0.2) at screening.
  13. Patients in need of urgent heart transplant within the next 6 months (patients on transplant list remain eligible).
  14. Sustained ventricular tachycardia (lasting > 30 seconds) on screening Holter.
  15. Significant liver disease (INR>1.4 off anticoagulant therapy; or AST, or ALT, or GGT, or alkaline phosphatase > 3X upper limit of normal; or bilirubin > 2X the upper limit of normal) at baseline.
  16. Failure to give informed consent
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00182169
 
2004h00512
Hamilton Health Sciences
 
Study Director: Catherine Demers, MD, MSc, FRCPC McMaster University
McMaster University
March 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP